Een korte cognitieve taakinterventie voor NHS-personeel dat getroffen is door COVID-19-trauma (GAINS-2-onderzoek) (GAINS-2)
Een gerandomiseerde, gecontroleerde studie van een korte cognitieve taakinterventie ter ondersteuning van NHS-personeel dat opdringerige herinneringen aan traumatische gebeurtenissen ervaart tijdens het werken in de COVID-19-pandemie.
Eerstelijnsgezondheidszorgpersoneel wordt vaak blootgesteld aan traumatische gebeurtenissen op het werk (bijvoorbeeld getuige zijn van het overlijden van patiënten), versterkt door de COVID-19-pandemie. Een aanzienlijk deel ervaart indringende herinneringen aan deze gebeurtenissen die plotseling in je opkomen: ze kunnen het functioneren verstoren en kunnen bijdragen aan een posttraumatische stressstoornis. Eerder onderzoek heeft aangetoond dat een korte gedragsinterventie het aantal intrusieve herinneringen na een traumatische gebeurtenis kan verminderen. In deze studie zullen we het effect testen van een digitale beeldconcurrerende taak, een digitale muziekluistertaak en behandeling zoals gewoonlijk (TAU) voor personeel van de National Health Service (NHS) met indringende herinneringen aan werkgerelateerde traumatische gebeurtenissen van de pandemie. We testen het effect op het aantal intrusieve herinneringen (primaire uitkomstmaat) en andere klinische symptomen (PTSS, angst, depressie en slapeloosheid), naast werkfunctioneren, algemeen functioneren en kwaliteit van leven (secundaire uitkomstmaten). Ook wordt gekeken naar de haalbaarheid, aanvaardbaarheid en implementatie van de interventie (aanvullende uitkomsten). We zullen ongeveer 150 NHS-medewerkers rekruteren (via de Intensive Care Society, sociale media en directe advertenties van NHS Trusts) met opdringerige herinneringen aan traumatische gebeurtenissen tijdens de COVID-19-pandemie.
De studie wordt gefinancierd door de Wellcome Trust (223016/Z/21/Z).
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Voorafgaand aan de eerste tussentijdse analyse zal een statistisch analyseplan worden opgesteld met behulp van Bayesiaanse analyses voor statistische inferentie.
P1vital Products zal regelmatig monitoren om te verifiëren dat het onderzoek wordt uitgevoerd en dat gegevens worden gegenereerd, gedocumenteerd en gerapporteerd in overeenstemming met het protocol, GCP en de toepasselijke wettelijke vereisten. Vertegenwoordigers voor kwaliteitsborging van de sponsor kunnen een audit van het onderzoek uitvoeren in overeenstemming met wettelijke richtlijnen en relevante standaardwerkprocedures.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Oxfordshire
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Wallingford, Oxfordshire, Verenigd Koninkrijk, OX10 8BA
- P1vital Products Ltd
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- 18 jaar of ouder.
- Engels kunnen lezen, schrijven en spreken.
- Tijdens de COVID-19-pandemie in een klinische rol gewerkt met COVID-19-patiënten in de NHS.
- Minstens één traumatische gebeurtenis meegemaakt die verband houdt met hun klinische werk tijdens de COVID-9-pandemie, voldoet aan criterium A van de Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria voor posttraumatische stressstoornis (PTSD): "blootstelling tot daadwerkelijke of dreigende dood, ernstig letsel of seksueel geweld" door "de traumatische gebeurtenis(sen) rechtstreeks te ervaren" of "persoonlijk getuige te zijn van de gebeurtenis(sen) zoals die anderen overkwam".
- Ervaar opdringerige herinneringen aan de traumatische gebeurtenis(sen).
- Minstens drie intrusieve herinneringen ervaren in de week voorafgaand aan de screening.
- Internettoegang hebben.
- Bereid en in staat om geïnformeerde toestemming te geven en studieprocedures te voltooien
- Bereid en in staat om tijdens de studieperiode gecontacteerd te worden door het onderzoeksteam.
- Niet hebben deelgenomen aan een eerdere studie van deze interventie van dit onderzoeksteam
Uitsluitingscriteria:
• Minder dan drie opdringerige herinneringen hebben tijdens de inloopweek.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Korte digitale beeldconcurrerende taak
Toegang tot een korte digitale beeldconcurrerende taak gedurende 24 weken (eerste 4 weken met optionele ondersteuning voor onderzoekers).
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Eerste sessie onder leiding van een onderzoeker: een geheugencue gevolgd door het spelen van een computerspel met instructies voor mentale rotatie. Mogelijkheid om deel te nemen aan zelfbeheerde/begeleide sessies na de eerste sessie. |
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Experimenteel: Korte digitale muziekluistertaak
Toegang tot een korte digitale muziekluistertaak gedurende 24 weken (eerste 4 weken met optionele ondersteuning voor onderzoekers).
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Eerste sessie onder leiding van een onderzoeker: informatie over de muziek van de componist, gevolgd door luisteren naar klassieke muziek. Mogelijkheid om deel te nemen aan zelfbeheerde/begeleide sessies na de eerste sessie. |
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Experimenteel: Behandeling zoals gewoonlijk
Toegang tot routinematige zorg die deelnemers anders zouden krijgen als ze gedurende 24 weken indringende herinneringen aan traumatische gebeurtenissen hebben.
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Toegang tot routinematige zorg die deelnemers anders zouden krijgen als ze opdringerige herinneringen aan traumatische gebeurtenissen hebben.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Intrusive Memories of Traumatic Event(s)
Tijdsspanne: Run-in/screening week, Week 4 (all arms)
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Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
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Run-in/screening week, Week 4 (all arms)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Slaapconditie-indicator (SCI)
Tijdsspanne: Basislijn, 4 weken, 12 weken en 24 weken (alle armen)
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Deze schaal met twee items meet slaapproblemen aan de hand van de DSM-5-criteria voor slapeloosheidsstoornis.
De itemreacties worden elk gescoord van 0-4, waarbij scores van 0 tot 2 de drempelcriteria voor slapeloosheidsstoornis aangeven.
De totale score varieert van 0-8, waarbij een hogere score een betere slaap aangeeft.
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Basislijn, 4 weken, 12 weken en 24 weken (alle armen)
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Number of Intrusive Memories of Traumatic Event(s)
Tijdsspanne: Run-in/Screening week, Weeks 12 and 24 (all arms)
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Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
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Run-in/Screening week, Weeks 12 and 24 (all arms)
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PTSD Checklist for DSM-5 (PCL-5)
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 20-item measure assesses symptoms of PTSD over the last week.
Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely").
Scores are summed to give a total severity score (ranging 0 to 80), with greater scores indicating greater symptom severity.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Generalised Anxiety Disorder 2-item Scale (GAD-2)
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 2-item short-form self-report measure assesses symptoms of anxiety.
Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day").
Total score is the sum of both items and ranges from 0 to 6, with greater scores indicating greater symptom severity.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Patient Health Questionnaire 2-item Version (PHQ-2)
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 2-item short-form self-report measure assesses symptoms of depression.
Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day").
Total score is the sum of both items and ranges from 0 to 6, with greater scores indicating greater symptom severity.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Total Score
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 19-item self-report measure assesses work engagement and burnout.
The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication).
The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness).
Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time).
The work engagement subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work engagement.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Total Score
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 19-item self-report measure assesses work engagement and burnout.
The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication).
The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness).
Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time).
The work burnout subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work burnout.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Sickness Absence
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Single item assessing self-reported number of sick days taken from work in the last 4 weeks.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Intention to Leave Job
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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3 items assess participants' intention to leave their job e.g.
"I think a lot about leaving the job", each rated from 1 (strongly agree) to 5 (strongly disagree).
The total score ranges 3 to 15, with a lower score indicating stronger intention to leave the job.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Mobility
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The mobility item is scored on a 5-point ordinal scale from "I have no problems in walking about" to "I am unable to walk about".
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Self Care
Tijdsspanne: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The self care item is scored on a 5-point ordinal scale from "I have no problems washing or dressing myself" to "I am unable to wash or dress myself".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Usual Activities
Tijdsspanne: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The usual activities item is scored on a 5-point ordinal scale from "I have no problems doing my usual activities" to "I am unable to do my usual activities".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Pain / Discomfort
Tijdsspanne: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The pain / discomfort item is scored on a 5-point ordinal scale from "I have no pain or discomfort" to "I have extreme pain or discomfort".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Anxiety / Depression
Tijdsspanne: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The anxiety / depression item is scored on a 5-point ordinal scale from "I am not anxious or depressed" to "I am extremely anxious or depressed".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Overall Health
Tijdsspanne: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief measure for assessing general quality of life and health status.
Respondents rate their overall health today on a visual analogue scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
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Baseline, Week 4, Week 12 and Week 24
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World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0)
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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The 12-item, self-report version of the WHODAS 2.0 will be used to assess difficulties in relation to the impact of intrusive memories.
Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 (none) to 4 (extreme or cannot do).
The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points), with greater scores indicating greater impairment.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Intrusive Memory Ratings: Item 1. Approximately How Often Did Intrusive Memories of the Traumatic Event Pop Into Your Mind?
Tijdsspanne: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present Item 1 assessing the frequency of intrusive memories on a 7-point scale from 'never' to 'many times a day'. Other items from this questionnaire are presented below. |
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Intrusive Memory Ratings: Item 4a. Duration of Interference
Tijdsspanne: Baseline, Week 4, Week 12 and Week 24 (all arms)
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This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present Item 4a assessing the for how long intrusive memories interfered with what participants were doing on a 7-point scale from '<1 min' to '>60 mins'. Other items from this questionnaire are presented below. |
Baseline, Week 4, Week 12 and Week 24 (all arms)
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Intrusive Memory Ratings: Distress (Item 2), Disruption to Concentration (Item 3), Interference (Item 4), Impact on Work Functioning (Item 5), and Impact on Functioning in Other Areas of Life (Item 7)
Tijdsspanne: Baseline, Week 4, Week 12 and Week 24 (all arms)
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This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present data for the five items scored on an 11-point scale (0=not at all to 10=extremely) assessing distress (Item 2), disruption to concentration (Item 3), interference (Item 4), impact on work functioning (Item 5), and impact on functioning in other areas of life (Item 7). |
Baseline, Week 4, Week 12 and Week 24 (all arms)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes to Health and Work - Dichotomous Outcomes
Tijdsspanne: 4 weeks, 12 weeks and 24 weeks (all arms)
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The 9-item questionnaire will be used to assess the occurrence and number of any new traumatic events, any additional stressful life events (e.g.
relationship problems, financial problems), new treatments received, untoward medical occurrences, changes to the job, or changes to the number of hours worked per week since the last assessment.
Dichotomous outcomes are presented below, and discrete outcomes with count data are presented under "Changes to health and work - discrete outcomes".
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4 weeks, 12 weeks and 24 weeks (all arms)
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Changes to Health and Work - Discrete Outcomes
Tijdsspanne: 4 weeks, 12 weeks and 24 weeks (all arms)
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The 9-item questionnaire will be used to assess the occurrence and number of any new traumatic events, any additional stressful life events (e.g.
relationship problems, financial problems), new treatments received, untoward medical occurrences, changes to the job, or changes to the number of hours worked per week since the last assessment.
Discrete outcomes are presented below, and dichotomous outcomes are presented under "Changes to health and work - dichotomous outcomes".
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4 weeks, 12 weeks and 24 weeks (all arms)
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Feedback Questionnaire
Tijdsspanne: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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A 12-item questionnaire assessing participants' experience of using the brief cognitive task.
The first ten items assess how easy, helpful, distressing, burdensome and acceptable participants found the brief cognitive task, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within the NHS, each rated from 0 (not at all) to 10 (very).
The last two items ask how the brief cognitive task could be improved, and for any other comments or suggestions about the brief cogntive task, both with an open response.
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After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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Feedback Questionnaire (Total Score)
Tijdsspanne: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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A 12-item questionnaire assessing participants' experience of using the brief cognitive task.
The first ten items assess how easy, helpful, distressing, burdensome and acceptable participants found the brief cognitive task, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within the NHS, each rated from 0 (not at all) to 10 (very); items for distress and burden are reverse scored from 0 (very) to 10 (not at all).
The last two items ask how the brief cognitive task could be improved, and for any other comments or suggestions about the brief cognitive task, both with an open response.
A total score of the eight categorical items is presented (range 0 - 80), with greater scores indicating more favourable feedback towards the allocated digital task.
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After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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Optional Qualitative Interview
Tijdsspanne: Week 4 and Week 24 (brief imagery competing task and brief music listening task arms only)
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This semi-structured interview will consist of a number of questions designed to gain an in-depth understanding of participants' experience of using the brief cognitive task, including acceptability, improvement suggestions, and potential barriers/facilitators to implementation.
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Week 4 and Week 24 (brief imagery competing task and brief music listening task arms only)
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Weekly Work Pattern, Number of Days Worked
Tijdsspanne: Baseline, Week 4, Week 12 and Week 24
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One item asses the number of days worked in the last week (both with responses from 0 to 7 days).
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Baseline, Week 4, Week 12 and Week 24
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Weekly Work Pattern, Number of Night Shifts Worked
Tijdsspanne: Baseline, Week 4, Week 12 and Week 24
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One item asses the number of night shifts worked in the last week (both with responses from 0 to 7).
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Baseline, Week 4, Week 12 and Week 24
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Expectancy of Intervention Effect (Credibility and Expectancy Questionnaire, CEQ) - Categorical Items
Tijdsspanne: Day 0 (post-randomisation)
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The Credibility and Expectancy Questionnaire (CEQ) consists of 6 items.
Items 1, 2, 3, and 5 were assessed on a 9-point integer scale ranging from 1 ("not at all") to 9 ("very").
Items 4 and 6 were assessed on an 11-point scale (response range of 0-100%) and, for comparability, were converted to the same 9-point scale as other items.
CEQ total score was calculated by summing all six items producing a possible total score range of 6-54; with greater scores indicating greater credibility and expectancy of intervention effect.
Participants completed the Credibility and Expectancy Questionnaire (CEQ) after being informed of treatment allocation (Day 0).
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Day 0 (post-randomisation)
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Expectancy of Intervention Effect (Credibility and Expectancy Questionnaire, CEQ) - Total Score
Tijdsspanne: Day 0 (post-randomisation)
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The Credibility and Expectancy Questionnaire (CEQ) consists of 6 items.
Items 1, 2, 3, and 5 were assessed on a 9-point integer scale ranging from 1 ("not at all") to 9 ("very").
Items 4 and 6 were assessed on an 11-point scale (response range of 0-100%) and, for comparability, were converted to the same 9-point scale as other items.
CEQ total score was calculated by summing all six items producing a possible total score range of 6-54; with greater scores indicating greater credibility and expectancy of intervention effect.
Participants completed the Credibility and Expectancy Questionnaire (CEQ) after being informed of treatment allocation (Day 0).
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Day 0 (post-randomisation)
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Emily Holmes, Uppsala University (UU), Sweden
- Hoofdonderzoeker: Amy Beckenstrom, P1vital Products, Wallingford
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P1V-GAINS-IN02
Plan Individuele Deelnemersgegevens (IPD)
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